{
  "companyId": "48447",
  "slug": "karl-storz-endoscopy-america-inc-48447",
  "name": "Karl Storz Endoscopy America Inc",
  "clearances": {
    "total": 367,
    "last12Months": 1,
    "first": "1980-04-21",
    "latest": "2026-05-15"
  },
  "medianReviewDays": 90,
  "productCodeCount": 82,
  "recalls": {
    "total": 19,
    "openLast12Months": 0,
    "recent": [
      {
        "resNumber": "Z-0526-2014",
        "productCode": "CAL",
        "status": "Terminated",
        "recallClass": "Class II",
        "initiated": "2013-11-13",
        "reason": "KARL STORZ Endoscopy America, Inc. is recalling the Flexible Broncho Fiberscope or a Flexible Intubation Fiberscope with a suction port because the material used in the suction channel portion was thermoplastic polyurethane (TPU), which is not listed in STERRAD systems claims for interior endoscope lumens."
      },
      {
        "resNumber": "Z-0527-2014",
        "productCode": "ECQ",
        "status": "Terminated",
        "recallClass": "Class II",
        "initiated": "2013-11-13",
        "reason": "KARL STORZ Endoscopy America, Inc. is recalling the Flexible Broncho Fiberscope or a Flexible Intubation Fiberscope with a suction port because the material used in the suction channel portion was thermoplastic polyurethane (TPU), which is not listed in STERRAD systems claims for interior endoscope lumens."
      },
      {
        "resNumber": "Z-0465-2014",
        "productCode": "GCJ",
        "status": "Terminated",
        "recallClass": "Class II",
        "initiated": "2013-11-06",
        "reason": "KARL STORZ is recalling the Axillent Debakey Grasping Forceps because the 33821WTD Wavy grasper was mislabeled as 33821DYD Axillent Debakey Grasping Forceps."
      },
      {
        "resNumber": "Z-1728-2013",
        "productCode": "GBA",
        "status": "Terminated",
        "recallClass": "Class II",
        "initiated": "2013-05-31",
        "reason": "Karl Storz Endoscopy-America has initiated the recall of the 27023WU Balloon Catheter because the packaging may be compromised, and therefore the sterility of the product could be affected."
      },
      {
        "resNumber": "Z-1216-2013",
        "productCode": "OAY",
        "status": "Terminated",
        "recallClass": "Class II",
        "initiated": "2012-08-16",
        "reason": "The recall was initiated because Karl Storz has confirmed that the Photodynamic Diagnosis (PDD) D-Light C System instruction manuals have important safety-related changes."
      }
    ]
  },
  "registration": {
    "sites": 2,
    "countries": [
      "US"
    ]
  },
  "productCodes": [
    {
      "code": "GCJ",
      "deviceName": "Laparoscope, General & Plastic Surgery",
      "clearances": 51,
      "latest": "2023-06-23",
      "medianReviewDays": 76
    },
    {
      "code": "HET",
      "deviceName": "Laparoscope, Gynecologic (And Accessories)",
      "clearances": 29,
      "latest": "2015-11-20",
      "medianReviewDays": 124
    },
    {
      "code": "EOB",
      "deviceName": "Nasopharyngoscope (Flexible Or Rigid)",
      "clearances": 28,
      "latest": "2020-08-11",
      "medianReviewDays": 55
    },
    {
      "code": "HRX",
      "deviceName": "Arthroscope",
      "clearances": 28,
      "latest": "2010-10-18",
      "medianReviewDays": 71
    },
    {
      "code": "EOQ",
      "deviceName": "Bronchoscope (Flexible Or Rigid)",
      "clearances": 13,
      "latest": "2021-12-29",
      "medianReviewDays": 49
    },
    {
      "code": "FET",
      "deviceName": "Endoscopic Video Imaging System/Component, Gastroenterology-Urology",
      "clearances": 13,
      "latest": "2022-05-13",
      "medianReviewDays": 96
    },
    {
      "code": "GEI",
      "deviceName": "Electrosurgical, Cutting & Coagulation & Accessories",
      "clearances": 13,
      "latest": "2017-08-02",
      "medianReviewDays": 54
    },
    {
      "code": "HIH",
      "deviceName": "Hysteroscope (And Accessories)",
      "clearances": 11,
      "latest": "2023-09-14",
      "medianReviewDays": 135
    },
    {
      "code": "GWG",
      "deviceName": "Endoscope, Neurological",
      "clearances": 10,
      "latest": "2018-04-17",
      "medianReviewDays": 86
    },
    {
      "code": "HIF",
      "deviceName": "Insufflator, Laparoscopic",
      "clearances": 9,
      "latest": "2017-03-02",
      "medianReviewDays": 258
    },
    {
      "code": "FAJ",
      "deviceName": "Cystoscope And Accessories, Flexible/Rigid",
      "clearances": 8,
      "latest": "2021-09-03",
      "medianReviewDays": 77
    },
    {
      "code": "FGB",
      "deviceName": "Ureteroscope And Accessories, Flexible/Rigid",
      "clearances": 7,
      "latest": "2022-01-20",
      "medianReviewDays": 142
    },
    {
      "code": "EOX",
      "deviceName": "Esophagoscope (Flexible Or Rigid)",
      "clearances": 6,
      "latest": "2005-08-15",
      "medianReviewDays": 25
    },
    {
      "code": "LNS",
      "deviceName": "Lithotriptor, Extracorporeal Shock-Wave, Urological",
      "clearances": 6,
      "latest": "2021-03-30",
      "medianReviewDays": 90
    },
    {
      "code": "OWN",
      "deviceName": "Confocal Optical Imaging",
      "clearances": 6,
      "latest": "2021-11-15",
      "medianReviewDays": 81
    },
    {
      "code": "ERL",
      "deviceName": "Drill, Surgical, Ent (Electric Or Pneumatic) Including Handpiece",
      "clearances": 5,
      "latest": "2020-10-22",
      "medianReviewDays": 108
    },
    {
      "code": "FBO",
      "deviceName": "Cystourethroscope",
      "clearances": 5,
      "latest": "2014-01-02",
      "medianReviewDays": 111
    },
    {
      "code": "FJL",
      "deviceName": "Resectoscope",
      "clearances": 5,
      "latest": "2023-03-17",
      "medianReviewDays": 85
    },
    {
      "code": "LJH",
      "deviceName": "System, Irrigation, Urological",
      "clearances": 5,
      "latest": "2017-07-07",
      "medianReviewDays": 105
    },
    {
      "code": "ODA",
      "deviceName": "Endoscopic Central Control Unit",
      "clearances": 5,
      "latest": "2012-01-06",
      "medianReviewDays": 102
    },
    {
      "code": "GCT",
      "deviceName": "Light Source, Endoscope, Xenon Arc",
      "clearances": 4,
      "latest": "2008-12-18",
      "medianReviewDays": 78
    },
    {
      "code": "HIG",
      "deviceName": "Insufflator, Hysteroscopic",
      "clearances": 4,
      "latest": "2000-11-30",
      "medianReviewDays": 196
    },
    {
      "code": "KCT",
      "deviceName": "Sterilization Wrap Containers, Trays, Cassettes & Other Accessories",
      "clearances": 4,
      "latest": "2021-07-06",
      "medianReviewDays": 151
    },
    {
      "code": "KNF",
      "deviceName": "Coagulator-Cutter, Endoscopic, Unipolar (And Accessories)",
      "clearances": 4,
      "latest": "1995-02-09",
      "medianReviewDays": 100
    },
    {
      "code": "LLZ",
      "deviceName": "System, Image Processing, Radiological",
      "clearances": 4,
      "latest": "2011-12-13",
      "medianReviewDays": 106
    }
  ],
  "productCodesShown": 25,
  "productCodesTotal": "82",
  "recentClearances": [
    {
      "kNumber": "K252624",
      "deviceName": "KARL STORZ Laryngoscopes and Accessories",
      "productCode": "EQN",
      "decisionDate": "2026-05-15",
      "reviewDays": 270
    },
    {
      "kNumber": "K240506",
      "deviceName": "KARL STORZ Holders",
      "productCode": "OCV",
      "decisionDate": "2024-10-22",
      "reviewDays": 244
    },
    {
      "kNumber": "K223885",
      "deviceName": "HOPKINS Telescopes",
      "productCode": "HIH",
      "decisionDate": "2023-09-14",
      "reviewDays": 261
    },
    {
      "kNumber": "K230359",
      "deviceName": "KOH Ultramicro Injection Cannula (26167NN); Suction a. Irrig. Cannula,L. 36cm (37360CP); Suction a. Irrig. Cannula,L. 36cm (37360SC); Suction and Irrig Cannula,l. 36cm (37560LH); Suction a. Irrig. Cannula,L. 30cm (37260LH); KOH Ultramicro Injection Needle (26167NA); Puncture Needle, LUER-lock (26178R); Suction a. Irrig. Cannula,L. 43cm (37460LH); Suction a. Irrig. Cannula,L. 36cm (37360LH); Puncture Needle, dia. 1.6 mm, 36 cm (26175R); Two-Way Stopcock (26167H); Injection Needle, LUER-",
      "productCode": "GCJ",
      "decisionDate": "2023-06-23",
      "reviewDays": 133
    },
    {
      "kNumber": "K223520",
      "deviceName": "UNIDRIVE SIII System",
      "productCode": "HIH",
      "decisionDate": "2023-04-27",
      "reviewDays": 155
    },
    {
      "kNumber": "K223923",
      "deviceName": "HOPKINS Telescopes",
      "productCode": "GCJ",
      "decisionDate": "2023-03-30",
      "reviewDays": 90
    },
    {
      "kNumber": "K221893",
      "deviceName": "KARL STORZ Bipolar Resectoscopes with HF Cable",
      "productCode": "FJL",
      "decisionDate": "2023-03-17",
      "reviewDays": 261
    },
    {
      "kNumber": "K221004",
      "deviceName": "HOPKINS Telescopes",
      "productCode": "GCJ",
      "decisionDate": "2022-12-20",
      "reviewDays": 259
    },
    {
      "kNumber": "K222504",
      "deviceName": "H1",
      "productCode": "GCJ",
      "decisionDate": "2022-11-10",
      "reviewDays": 84
    },
    {
      "kNumber": "K213194",
      "deviceName": "HD Mediastinoscope",
      "productCode": "EWY",
      "decisionDate": "2022-06-23",
      "reviewDays": 267
    }
  ],
  "nameVariants": {
    "total": "9",
    "shown": [
      {
        "name": "KARL STORZ ENDOSCOPY-AMERICA, INC.",
        "dataset": "device/registrationlisting",
        "method": "normalised"
      },
      {
        "name": "KARL STORZ Endoscopy-America, Inc.",
        "dataset": "device/510k",
        "method": "normalised"
      },
      {
        "name": "Karl Storz Endoscopy America",
        "dataset": "device/510k",
        "method": "normalised"
      },
      {
        "name": "Karl Storz Endoscopy America Inc",
        "dataset": "device/enforcement",
        "method": "normalised"
      },
      {
        "name": "Karl Storz Endoscopy America Inc",
        "dataset": "device/recall",
        "method": "normalised"
      },
      {
        "name": "Karl Storz Endoscopy America, Inc.",
        "dataset": "device/510k",
        "method": "normalised"
      },
      {
        "name": "Karl Storz Endoscopy-America, Inc.",
        "dataset": "device/registrationlisting",
        "method": "normalised"
      },
      {
        "name": "Karl Storz Endoscopy_America, Inc.",
        "dataset": "device/510k",
        "method": "normalised"
      }
    ]
  },
  "sources": {
    "clearances": "https://api.fda.gov/device/510k.json?search=applicant%3A%22Karl%20Storz%20Endoscopy%20America%20Inc%22",
    "recalls": "https://api.fda.gov/device/recall.json?search=recalling_firm%3A%22Karl%20Storz%20Endoscopy%20America%20Inc%22"
  },
  "provenance": [
    {
      "dataset": "device/510k",
      "loadedAt": "2026-08-10T19:40:09Z",
      "ingestRun": 51
    },
    {
      "dataset": "device/classification",
      "loadedAt": "2026-08-10T06:54:18Z",
      "ingestRun": 2
    },
    {
      "dataset": "device/enforcement",
      "loadedAt": "2026-08-10T19:40:12Z",
      "ingestRun": 53
    },
    {
      "dataset": "device/event",
      "loadedAt": "2026-08-11T13:58:22Z",
      "ingestRun": 74
    },
    {
      "dataset": "device/recall",
      "loadedAt": "2026-08-10T19:40:11Z",
      "ingestRun": 52
    },
    {
      "dataset": "device/registrationlisting",
      "loadedAt": "2026-08-10T07:06:24Z",
      "ingestRun": 10
    }
  ],
  "retrievedAt": "2026-08-11T14:48:53.022Z"
}